BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPEL SINUS IMPLANT

    MDR report key: 3049552 · Received April 5, 2013

    Report

    Report Number
    3008301917-2013-00001
    Event Type
    Injury
    Date Received
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    INTERSECT ENT
    Product Code
    OWO
    PMA / PMN Number
    P100044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY HAS MADE MULTIPLE UNSUCCESSFUL REQUESTS FOR ADD'L INFO REGARDING THE PT'S MEDICAL HISTORY AND CURRENT STATUS, THE EVENT, AND THE DEVICE. (NOTE THAT THE DEVICE CANNOT BE RETURNED FOR EVALUATION BECAUSE IT IS A RESORBABLE DRUG-ELUTING SINUS STENT.) THE COMPANY HAS REACHED OUT TO THE SURGEON TO REQUEST ADD'L DETAIL REGARDING THIS EVENT, BUT HAS NOT REC'D ANY ADD'L INFO AT THIS TIME. THE SURGEON INDICATED THAT HE BELIEVES THE PT WILL NEED REVISION SURGERY, BUT IT IS UNK AT THIS TIME, WHETHER THE PT HAS HAD OR WILL HAVE REVISION SURGERY OR WHETHER THE PT REC'D ANY OTHER TREATMENT. DUE TO THE LIMITED AMOUNT OF INFO THAT THE COMPANY CURRENTLY POSSESSES REGARDING THIS REPORTED EVENT, IT IS NOT POSSIBLE TO PERFORM A FULL CAUSATION ASSESSMENT AT THIS TIME. IT REMAINS UNK WHAT ROLE, IF ANY, PROPEL PLAYED IN THIS EVENT. THIS REPORT WILL BE SUPPLEMENTED AS NECESSARY AS ADD'L INFO IS REC'D.

    Description of Event or Problem · 1

    INTERSECT ENT WAS NOTIFIED ON (B)(6) 2013, OF A PT THAT WAS REPORTED TO HAVE EXPERIENCED "SEVERE SCARRING" APPROXIMATELY TWO MONTHS FOLLOWING SINUS SURGERY AND PLACEMENT OF PROPEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139745 PROPEL SINUS IMPLANT OWO INTERSECT ENT 70011

    Patients

    Seq Age Sex Outcome Treatment
    1